CMS Manual System

[Pages:242]CMS Manual System

Pub. 100-16 Medicare Managed Care

Transmittal 91

Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS)

Date: AUGUST 7, 2009

SUBJECT: Chapter 3, "Medicare Marketing Guidelines"

I. SUMMARY OF CHANGES: As part of the implementation of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, CMS has revised the Medicare Marketing Chapter to include the latest provisions and clarifications in the current guidance. This revision replaces Chapter 3, "Medicare Marketing Guidelines."

NEW / REVISED MATERIAL = EFFECTIVE DATE: August 7, 2009 IMPLEMENTATION DATE: August 7, 2009

Disclaimer for manual changes only: Normally, red italic font identifies new material. However, because this release is a complete rewrite of the chapter, normal text font is used for this revision.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual not updated.) (R = REVISED, N = NEW, D = DELETED) ? (Only One Per Row.)

R/N/D CHAPTER/SECTION/SUBSECTION/TITLE

R

3/Medicare Marketing Guidelines

R

3/Appendix 1/Summary of Benefits

R

3/Appendix 2/Attestation Form for Translated Non-English Materials or

Alternate Materials

R

3/Appendix 3/Plan Sponsor Website Must Use Chart

R

3/Appendix 4/Model File and Use Certification Form

III. FUNDING: No additional funding is currently provided by CMS; contractor activities are to be carried out within their own FY 2009 and/or future operating budgets determined by the organizations.

IV. ATTACHMENTS:

Business Requirements X Manual Instruction

Confidential Requirements One-Time Notification Recurring Update Notification

*Unless otherwise specified, the effective date is the date of service.

Chapter 3 ? Medicare Marketing Guidelines

For Medicare Advantage Plans, Medicare Advantage Prescription Drug Plans, Prescription Drug Plans, and 1876 Cost Plans

____________________________________________________________________________

Table of Contents

(Rev. 91, 08-07-09)

10 Introduction 20 Definitions 30 Plan Sponsor Responsibilities

30.1 Limitations on Distribution of Marketing Materials 30.2 Co-branding Requirements

30.2.1 Co-branding with network providers 30.2.2 Co-Branding with State Pharmaceutical Assistance Programs (SPAP) 30.3 Provider Name in Plan's Name or Downstream Entity's Name 30.4 Use of Data from Medigap Issuers 30.5 Plan Sponsor Responsibility for Subcontractor Activities and Submission of Materials for CMS Review 30.5.1 Multiple Organization Marketing Pieces Created by Agents 30.6 Anti-Discrimination 30.7 Requirements for Plan Sponsors with Non-English Speaking Populations or Populations with Special Needs 30.8 Compliance with Section 508 of the Rehabilitation Act 30.9 Materials Required for Program Start-up 30.9.1 Required Materials in Enrollment Package (Pre-Enrollment) 30.9.2 Required Materials for New and Renewing Members at Time of Enrollment and Annually Thereafter 30.9.3 Required Ongoing Materials for New and Renewing Members 30.10 Hold Time Messages 30.11 Use of the Medicare Name 30.12 Referral Programs 30.13 Privacy and Confidentiality 30.14 Plan Ratings Information from

40 General Marketing Requirements

40.1 Marketing Material Identification Number 40.1.1 Marketing Material Identification Number for Non-English or Alternate Materials

40.2 Font Size Rule 40.3 Footnote Placement 40.4 Reference to Studies or Statistical Data 40.5 Prohibited Terminology/Statements

40.6 Statements Related to Claim Forms and Paperwork 40.7 Logos/Tag Lines 40.8 Identification of All Plans in Materials 40.9 Marketing to Beneficiaries of Non-Renewing Medicare Plans 40.10 Product Endorsements/Testimonials 40.11 Customer Service Hours of Operation 40.12 Use of TTY Numbers 40.13 Additional Materials Enclosed with Required Post Enrollment Materials 40.14 Marketing of Multiple Lines of Business

40.14.1 Multiple Lines of Business-General Information 40.14.2 Multiple Lines of Business - Exceptions 40.14.3 Multiple Lines of Business ? Television 40.14.4 Multiple Lines of Business ? Internet 40.14.5 Multiple Lines of Business - HIPAA Privacy Rule 40.14.6 Multiple Lines of Business- Non-Benefit/Service-Providing Third Party Marketing Materials 40.15 Providing Materials in Alternate Formats/Media Types 40.16 Standardization of Plan Name Type

50 Marketing Material Types and Applicable Disclaimers

50.1 Guidance and Disclaimers that Apply to All Materials 50.1.1 Federal Contracting Statement 50.1.2 Benefit Changes 50.1.3 Additional Guidance Applicable to All PFFS Plan Materials 50.1.4 Additional Guidance for SNP Materials 50.1.5 Plan Sponsor Responsibility -Disclaimer When Providing Third Party Marketing Materials 50.1.6 Plan Sponsor Responsibility -Disclaimer for Materials that are Co-branded with Providers 50.1.7 Applicable Disclaimers for the Marketing of Educational Events

50.2 Specific Guidance Applicable to General Advertising Materials 50.2.1 Radio Advertisements 50.2.2 Television Advertisements

50.3. Applicable Disclaimer When Benefits Are Mentioned 50.3.1 Disclaimers on Advertisements and Invitations to Sales/Marketing Events 50.3.2 Disclaimers Applicable to Advertising that Promotes a Nominal Gift

50.4 Explanatory Marketing Materials 50.5 Guidance and Disclaimers Applicable to Explanatory Marketing Materials

50.5.1 Required Access Information Disclaimers 50.5.2 Enrollment Limitations 50.5.3 Explanatory Marketing Materials that Mention Benefit and Plan Premium Information 50.5.4 Pharmacy Network Limitations 50.5.5 Online Enrollment Center Disclaimer 50.5.6 Eligibility Requirement Disclaimers 50.5.7 Availability of Medicare Subsidy Information 50.5.8 Availability of Alternate Formats

50.5.9 Additional Guidance for Preferred Provider Organization (PPO) Plans 50.5.10 Additional Guidance for PFFS Plans 50.5.11 Additional Guidance for 1876 Cost Plans 50.6 Plan Sponsor Mailing Statements on Envelopes/Mailing Itself

60 Specific Guidance on Required Documents

60.1 Summary of Benefits (SB) 60.2 Part D ID Card Requirements 60.3 ID Card Information for MA PPOs and PFFS 60.4 Directories 60.4.1 Pharmacy Directories

60.4.2 Provider Directories 60.4.3 PCP and Specialty Directories 60.4.4 Combined Provider/Pharmacy Directory 60.4.5 Mailing the Provider/Pharmacy Directory to Addresses with Multiple Members 60.4.6 Changes to Provider Network 60.5 Formulary and Formulary Change Notice Requirements 60.5.1 Abridged Formulary 60.5.2 Comprehensive Formulary 60.5.3 Changes to Printed Formularies 60.5.4 Formularies Provided on Plan Websites 60.5.5 Other Formulary Documents 60.5.6 Provision of Notice to Beneficiaries Regarding Formulary Changes 60.5.7 Provision of Notice to Other Payers Regarding Formulary Changes 60.6 Explanation of Benefits 60.7 Annual Notice Of Change (ANOC) and Evidence of Coverage (EOC)

70 Promotional Activities, Events, and Outreach

70.1 General Guidance about Promotional Activities 70.2 Nominal Gifts

70.2.1 Exclusion of Meals as a Nominal Gift 70.2.2 Nominal Gift Disclaimer 70.3 Unsolicited E-mail Policy 70.4 Marketing through Unsolicited Contacts 70.5 Specific Guidance on Telephonic Contact 70.5.1 Specific Guidance on Third-party Contact 70.6 Outbound Education and Verification Calls to All New Enrollees 70.7 Educational Events 70.7.1 Educational Event Disclaimer 70.8 Health Fairs and Health Promotional Events 70.8.1 Additional Sole Sponsor Policies 70.8.2 Additional Multiple-Sponsor Policies 70.8.3 Provider Participation in Health Fairs 70.9 Marketing/Sales Events 70.9.1 Additional Guidance for Marketing Events in the Provider Setting 70.9.2 Plan Activities and Materials in the Health Care Setting 70.9.3 Provider-Based Activities 70.9.4 Provider Affiliation Information

70.9.5 SNP Provider Affiliation Information 70.9.6 Comparative and Descriptive Plan Information 70.9.7 Comparative and Descriptive Plan Information Provided by a NonBenefit/Service Providing Third-Party 70.9.8 Providers/Provider Group Websites 70.10 Personal/Individual Marketing Appointments 70.10.1 Scope of Appointment 70.10.2 Beneficiary Walk-ins to a Plan or Agent/Broker Office or Similar BeneficiaryInitiated Face-to- Face Sales Event 70.11 Specific Guidance on Outreach to Dual Eligible Members 70.11.1 Guidance on Dual Eligibility 70.11.2 Guidance for Dual Eligible Outreach Program 70.11.3 Outreach Submission Requirements 70.11.4 CMS Review/Approval of Outreach Process 70.11.5 Reviewing New Outreach Programs 70.11.6 Reviewing Previously Approved Outreach Programs 70.12 PFFS Plan Provider Education and Outreach Programs 70.12.1 PFFS Plan Staff Requirement for Assisting Providers 70.12.2 PFFS Plan Terms and Conditions of Payment Contact and Website Fields in HPMS 70.13 Requirement that All Plans Give Beneficiaries Notice of Sales Event Cancellations

80 Special Guidance on Telephonic Scripts and Activities

80.1 Customer Service Call Center Requirements 80.1.1 Pharmacy Technical Help Call Center 80.1.2 Coverage Determinations and Appeals Call Center 80.1.3 Required Inbound Informational/Customer Service Telephone

80.2 Enrollment via Inbound Telephone 80.3 Telephonic Sales Scripts

90 Guidance on the Marketing Review Process

90.1 Plan Sponsor Responsibilities 90.2 Material Submission Process

90.2.1 Mandatory Use of Marketing Material Review Checklists for All Documents 90.3 Material Disposition Definitions

90.3.1 Approved Disposition 90.3.2 Disapproved Disposition 90.3.3 Deemed Disposition 90.3.4 Withdrawn Disposition 90.3.5 Additional Service Area (SA)/Low Income Subsidy (LIS) Materials 90.4 Alternate Format 90.5 Time Frames for Marketing Review 90.5.1 45-Day Standard Review Period 90.5.2 10-Day Model Review Period 90.6 File & Use Program Overview 90.6.1 Materials Qualified for the File & Use Submission 90.6.2 Materials Not Qualified for File & Use Submission 90.6.3 Restriction on the Manual Review of File & Use Eligible Materials

90.6.4 Loss of File & Use Certification Privileges 90.7 Additional Guidance for CMS Provided Language/Materials

90.7.1 Standardized Language 90.7.2 Standardized Materials 90.7.3 Model Materials 90.8 Template Materials 90.8.1 Submission of Template Materials 90.9 Expedited Review Process for Template Annual Renewal Materials 90.9.1 Eligibility for Participation in the Expedited Process 90.9.2 Submission of Templates under the Expedited Review Process 90.10 Submission of Non-English (*Alternate Formats) Materials 90.11 Acceptable Formats 90.12 Submissions Outside of HPMS 90.13 Requirements for Joint Enterprise for PDPs and Regional Preferred Provider Organizations (RPPOs) 90.14 Multi-Contract Entities (MCEs) 90.15 Review of Materials in the Marketplace 90.16 File & Use Retrospective Monitoring Reviews 90.16.1 Template Materials Quality Review and Reporting of Errors 90.17 Specific Guidance on the Submission of Websites for Review 90.18 Special Guidance on the Submission of SB and ANOC/EOC 90.19 Specific Guidance on the Submission of General Advertising Materials 90.20 Materials Not Subject To Review

100 Special Guidance on Plan Sponsor Websites

100.1 Plan Sponsor Website Requirements 100.2 Organization Website Content

100.2.1 Pharmacy Access Information 100.2.2 Provider Access information 100.2.3 Specific Guidance Regarding Grievance, Coverage Determination (including Exceptions) and Appeals Website Requirements 100.2.4 Low Income Subsidy (LIS) Website Premium Summary Table for People Receiving Extra Help 100.3 Required Links 100.3.1 Prohibited Links 100.4 Required Disclaimers on Websites 100.5 Enrollment via the Internet 100.5.1 Required Materials When Online Enrollment is Utilized

110 Specific Guidance about Value-Added Items and Services

110.1 Definition of Value-Added Items and Services (VAIS) 110.2 VAIS Examples 110.3 CMS Review of VAIS Materials 110.4 Further Requirements on VAIS 110.5 Value Added Items and Services Provided to Employer Groups

120 Guidance on Marketing and Sales Oversight and Responsibilities

120.1 Compliance with State Appointment Laws 120.2 Plan Reporting of Terminated Agents

120.3 Agent/Broker Training and Testing 120.4 Agent/Broker Use of Marketing Materials 120.5 Agent/Broker Compensation

120.5.1 Definition of Compensation 120.5.2 Compensation Types 120.5.3 Compensation Cycle (6-Year Cycle) 120.5.4 Specific Guidance for Developing and Implementing Compensation Strategy 120.5.5 Compensation Calculation 120.5. 6 Specific Guidance for Recovering Compensation Payments (Charge-backs) 120.5.7 Guidance for the 2010 Plan Year and Beyond 120.5.8 Third Party Marketing Entities 120.6 Activities That Do Not Require the Use of State-Licensed Marketing Representatives

130 Guidelines Applicable to Employer/Union Group Health Plans 140 Special Guidance for Medicare Medical Savings Account (MSA) Plans

140.1 General Advertising Materials 140.2 Explanatory Marketing Materials Requirements 140.3 Outbound Education and Verification Calls

150 Use Of Medicare Mark For Part D Plans

150.1 Authorized Users for Medicare Mark 150.2 Use of Medicare Prescription Drug Benefit Program Mark on Items for Sale or Distribution 150.3 Approval to Use the Medicare Prescription Drug Benefit Program Mark 150.4 Restrictions on Use of Medicare Prescription Drug Benefit Program Mark 150.5 Prohibition on Misuse of the Medicare Prescription Drug Benefit Program Mark 150.6 Mark Guidelines

150.6.1 Mark Guidelines - Negative Program Mark 150.6.2 Mark Guidelines - Approved Colors 150.6.3 Mark Guidelines on Languages 150.6.4 Mark Guidelines on Size 150.6.5 Mark Guidelines on Clear Space Allocation 150.6.6 Mark Guidelines on Bleed Edge Indicator 150.6.7 Mark Guidelines on Incorrect Use 150.7 Part D Standard Pharmacy ID Card Design

Appendices Appendix 1: Summary of Benefits Appendix 2: Attestation Form for Translated Non-English Materials or Alternate Materials Appendix 3: Plan Sponsor Website Must Use Chart Appendix 4: Model File & Use Certification Form

10 - Introduction

(Rev. 91; Issued: 08-07-09; Effective/Implementation Date: 08-07-09)

These Marketing Guidelines reflect the Centers for Medicare & Medicaid Service (CMS) current interpretation of the marketing requirements and related provisions of the Medicare Advantage (MA) and Medicare Prescription Drug Plan (PDP) rules (Chapter 42 of the Code of Federal Regulations, Parts 422 and 423). These Guidelines are for use by Medicare Advantage organizations offering MA plans and MA prescription drug (MA-PD) plans, and Prescription Drug plans (PDPs). Some of the provisions in this chapter also have applicability to Section 1876 Cost contracts for materials and activities aimed at Medicare beneficiaries, Medicare age-ins, and their caregivers. These marketing guidelines are not applicable for the Program of All-Inclusive Care for the Elderly (PACE) plans since PACE plans are governed by separate guidance which is not discussed in this document.

NOTE:

The provisions in this chapter provide sub-regulatory operational guidance. While most of the guidance in this chapter may not apply directly to Medicare 1876 Cost Plans, CMS encourages cost contractors to follow instructions that are addressed to MA-only plans. Cost plans that mention Part D as an optional supplemental benefit in their marketing materials should follow MA-PD guidance.

The scope of the term marketing, as used in the Medicare statute and CMS regulations extends beyond the public's general concept of advertising materials. Pursuant to 422.2260 and 423.2260 of Chapter 42 of the Code of Federal Regulations, marketing materials include any informational materials targeted to Medicare beneficiaries which are defined in ?20.

In addition, CMS' definition of marketing extends beyond materials to include activities, conducted by the plan sponsor or an individual or organization on behalf of the plan sponsor, that include steering, or attempting to steer, a potential enrollee towards a plan, or limited number of plans, for which the individual or entity performing marketing activities expects compensation directly or indirectly for such marketing activities. As such, CMS' authority for marketing oversight extends to include a range of different marketing materials and activities.

It is important to note that the marketing guidance set forth in this document is subject to change as communication technology and industry marketing practices continue to evolve. Moreover, the examples of marketing materials and promotional activities given in these Guidelines are not all-inclusive. Plan sponsors should apply the principles outlined in these Guidelines to all relevant decisions, situations, and materials. Any new rule-making or interpretative guidance (e.g., call letter or Health Plan Management System (HPMS) guidance memoranda) may update the marketing guidance provided here, and sound judgment and consultation with CMS Account Managers should be used in situations where new guidance updates the guidance provided in this document. Specific questions regarding a marketing material or any marketing practice should be directed to the plan's Account Manager or designated Marketing Reviewer.

20 - Definitions

(Rev. 91; Issued: 08-07-09; Effective/Implementation Date: 08-07-09)

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